Michael Amar Email
Internationnal regulatory affairs @ Rafa Laboratories
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Michael Amar Location
- Israel
Michael Amar Work
- 2020 -now Internationnal regulatory affairs @
- 2015 -2019 R and D Project Manager @
- 2015 -2019 Stemcell Medicine Ltd. Responsible Pharmacist QP and Regulatory Affairs Pharmacist @
- 2014 -2015 Regulatory Affairs, Deputy QP and Deputy QP PV Pharmacist @
- 1998 -2012 R and D Project Manager and Responsible Pharmacist @
- 1996 -1998 Pharmacist @ Superpharm
- 1995 -1995 Pharmacy school 6th year and DEA (a postgraduate degree granted 5 years @ Structural Biology & Protein Engineering dep, National Scientific Research Cente
Michael Amar Education
- Israeli Health Ministry Pharmacists Licence exam
Pharmacists Licence
2013-1996 - Oulpan Etsion Jerusalem
(Hebrew intensive courses)
1996-1996 - University Paul Sabatier Toulouse III
Master with These (Molecular modeling)
1993-1995 - University Paul Sabatier Toulouse III
State Diploma of Doctor in Pharmacy (Industry and Research specialization)
1988-1995 - Fermat high school in Toulouse 1987-1988
- Israeli Health Ministry
Appointed Pharmacist approval, based on previous working experience
2013 - High School Muret
High School Diploma (Mathematics & Physics)
2013 - Israeli Health Ministry 2013
Michael Amar Skills
- 14 years experience in Generic drugs formulation development
- Scale up and process validation
- CTD format Registration file redaction according to EU and IL guides
- Submission strategy determination and answer to defficiency letters
- Familiar with JV with Eueopean generic companies like STADA GmbH
- 9 years experienced Responsible Pharamcist exempted from QP courses
- Pharmacist diplomed from France (EU) able to be QP for EU
- French: mother tongue
- English: working knowledge
- French
- V&V
- Determination
- Redaction
- English
- Generic Drugs
- Regulatory Affairs
- Formulation
- Pharmaceutical Industry
- FDA
- Regulatory Submissions
- CAPA
- Generic Programming
- Validation
- R&D
- GMP
Michael Amar Summary
- Michael Amar, based in Israel, is currently a Internationnal regulatory affairs at Rafa Laboratories. Michael Amar brings experience from previous roles at Mapi Pharma, Tec-O-Pharm Group and Dexcel Pharma. Michael Amar holds a 2013 - 1996 Pharmacists Licence @ Israeli Health Ministry Pharmacists Licence exam. With a robust skill set that includes 14 years experience in Generic drugs formulation development, Scale up and process validation, CTD format Registration file redaction according to EU and IL guides, Submission strategy determination and answer to defficiency letters, Familiar with JV with Eueopean generic companies like STADA GmbH and more. Michael Amar has 3 emails on RocketReach.
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